drugset / Trial / NCT05815082

ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer

NCT05815082 ↗

Phase 3 Recruiting 490 enrolled Sixth Affiliated Hospital, Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to compare in resectable colorectal cancer liver metastasis patients.The main question it aims to answer is whether the 3-year progression-free survival rate (PFS) of "watching and waiting" is non-inferior to adjuvant chemotherapy in postoperative ctDNA-negative resectable colorectal cancer liver metastasis patients.Participants will undergo ctDNA testing after resection of colorectal cancer liver metastasis, and will be randomly assigned to receive adjuvant chemotherapy or "watching and waiting" treatment strategy. The researchers will compare the outcomes between the two groups to see if the PFS between the two groups is similar.

Timeline

Start
2023-02-20
Primary completion
2031-02-20
Completion
2033-02-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule — —
Comparator FOLFOX chemotherapy regimen Unknown — —
Comparator Oxaliplatin Small molecule — —
Comparator fluorouracil Small molecule — —